NDC 0078-0372

Ritalin LA

Methylphenidate Hydrochloride

Ritalin LA is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Methylphenidate Hydrochloride.

Product ID0078-0372_238e17d0-f928-47d5-a6c8-1b846f994b9f
NDC0078-0372
Product TypeHuman Prescription Drug
Proprietary NameRitalin LA
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2002-06-05
Marketing CategoryNDA / NDA
Application NumberNDA021284
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0372-05

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0372-05)
Marketing Start Date2002-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0372-05 [00078037205]

Ritalin LA CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-06-05

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:effd952d-ac94-47bb-b107-589a4934dcca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806183
  • 1091167
  • 1091143
  • 1806177
  • 1806179
  • 1806195
  • 1091197
  • 1091182
  • Pharmacological Class

    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]

    NDC Crossover Matching brand name "Ritalin LA" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0078-0370Ritalinmethylphenidate hydrochloride
    0078-0371Ritalinmethylphenidate hydrochloride
    0078-0372Ritalinmethylphenidate hydrochloride
    0078-0424Ritalinmethylphenidate hydrochloride
    0078-0439Ritalinmethylphenidate hydrochloride
    0078-0440Ritalinmethylphenidate hydrochloride
    0078-0441Ritalinmethylphenidate hydrochloride

    Trademark Results [Ritalin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RITALIN
    RITALIN
    71560984 0517928 Live/Registered
    CIBA LIMITED
    1948-07-09

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.